Effectiveness of Two Icodextrin Exchanges on Fluid Status and Blood Pressure Control Compared to a Single Icodextrin Exchange

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorNational University Health System, Singapore

About this trial

Fluid overload and hypertension are prevalent in children undergoing chronic peritoneal dialysis (PD), especially in low- and middle-income countries (LMICs). These complications often lead to increased hospitalizations, higher medication use, and, in some cases, conversion to hemodialysis. Icodextrin is used to enhance ultrafiltration (UF) and reduce glucose exposure, but its effectiveness in children with a single long dwell has been inconsistent. Preliminary observations suggest that shorter, twice-daily icodextrin exchanges may improve UF and blood pressure (BP) control. However, no randomized trial has evaluated this approach in pediatric patients.

Eligibility criteria

Qualifiers

Children 5-18 years of age

Receiving CAPD or CCPD for at least the preceding 4 weeks, and not likely to change from CAPD to CCPD during the study period

24-hour mean arterial pressure (MAP; measured by ambulatory blood pressure monitoring (ABPM) above the 95th percentile for age, sex, and height

24-hour urine output less than 200ml/day

Disqualifiers

Children under 5 years of age (as younger children are more prone to hyponatremia)

Children with systolic BP < 50th centile for age, sex, and height in the preceding 4 weeks)

Children who are polyuric or those prone to hypotension (defined as > 2 episodes of systolic BP < 5th centile in the 4 weeks preceding the study)

Known allergy to starch

Trial design

Treatments tested in this trial

  • One icodextrin exchange
  • Two icodextrin exchanges

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators

National University Health System, Singapore

Lead sponsor

The UCL Great Ormond Street Institute of Child Health

Collaborator

Children's Hospital of Fudan University

Collaborator

Philippine Children's Medical Center

Collaborator